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04/13/06 | 103 views | #20060079003 | Prev - Next | USPTO Class 436 | About this Page  436 rss/xml feed  monitor keywords

Apparatus and method for a precision flow assay

USPTO Application #: 20060079003
Title: Apparatus and method for a precision flow assay
Abstract: A flow cell system includes a housing, a mixing chamber and a flow channel sized to provide for movement of liquid from the mixing chamber by non-capillary action. A monitoring device is coupled to the matrix. A fluid moving source is coupled to the flow channel. A matrix is coupled to a distal end of the flow channel and contains a compound that will react with the sample to create a change detectable by the monitor device. A fluid path extends from the mixing chamber to the flow channel and to the matrix to bring sample fluid to the matrix for detection of analyte levels therein. (end of abstract)
Agent: Heller Ehrman LLP - Menlo Park, CA, US
Inventors: Thomas R. Witty, Robert Case, Scott Castanon
USPTO Applicaton #: 20060079003 - Class: 436180000 (USPTO)
Related Patent Categories: Chemistry: Analytical And Immunological Testing, Including Sample Preparation, Volumetric Liquid Transfer
The Patent Description & Claims data below is from USPTO Patent Application 20060079003.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords



CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Ser. No. 60/618,278 filed Oct. 12, 2004, which application is fully incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates generally to methods and systems for analyzing fluid samples and, more specifically, to methods and systems for using a flow channel to control sample fluid incubation.

[0004] 2. Description of the Related Art

[0005] Blood and other body fluid tests are important diagnostic methods in patient care and treatment. The reliability and the accuracy of the tests are critical in correctly diagnosing the patient and administrating proper treatment. The Food and Drug Administration (FDA) has established numerous quality standards for the various blood or body fluid tests. Monitoring the test process is beneficial in producing reliable and accurate test results.

[0006] One way of monitoring the test process is periodically performing the monitoring test on standard test samples. The monitoring test results are compared with expected results to verify the accuracy of the test processes or correct the test instrument or process when appropriate. In this approach, the test processes are assumed to generate consistent result between the monitoring tests.

[0007] Another way of monitoring the test process is including standard test samples in the test process. This approach is suitable for a test process that performs tests on multiple samples. The test results on the standard test samples are compared with expected results to verify the accuracy of the test processes. In this approach, the test processes on real samples are assumed to generate result consistent with those on standard test samples.

[0008] These monitoring processes are time and cost inefficient. They are deficient in meeting the needs of point of care, e.g., emergency room, test processes. In addition to being reliable and accurate, an emergency room test process should be simple to operate and generate results fast.

[0009] Accordingly, it would be advantageous to have an apparatus and a method for monitoring a test process that is simple, and reliable. It is desirable for the test apparatus to be compact and capable of generating test results fast thereby meeting the need of the emergency rooms. It would be of further advantage for the apparatus and method to be easily adaptable for monitoring different test processes. Additionally, some tests require specific preparation of the fluid sample prior to testing. Some may desire certain incubation time before the fluid sample is tested. It would be advantageous to provide an apparatus and a method for properly preparing the sample for testing.

SUMMARY OF THE INVENTION

[0010] An object of the present invention is to provide improved methods and systems for monitoring a test processes in real time.

[0011] Another object of the present invention is to provide methods and systems for monitoring test processes that performs a comparison of a timing of the introduction, and the exit of a sample to and from a measurement chamber, in order to confirm of a point in time of a valid reaction of the sample in the measurement chamber.

[0012] Yet another object of the present invention is to provide methods and systems for monitoring test processes that directly monitors the flow of a sample and a reagent into a measurement chamber.

[0013] These and other objects of the present invention are achieved in a flow cell system that includes a housing, a mixing chamber and a flow channel sized to provide for movement of liquid from the mixing chamber by non-capillary action. A monitoring device is coupled to the matrix. A fluid moving source is coupled to the flow channel. A matrix is coupled to a distal end of the flow channel and contains a compound that will react with the sample to create a change detectable by the monitor device. A fluid path extends from the mixing chamber to the flow channel and to the matrix to bring sample fluid to the matrix for detection of analyte levels therein.

[0014] In another object of the present invention, a method is provided for analyzing a sample for the presence of an analyst. The sample is introduced into a test device that includes a non-microporus mixing chamber, flow channel and a matrix. The sample flows from the mixing chamber through the flow channel to the matrix by non-capillary flow. The sample is contacted with the matrix which contains a compound that will react with the sample. A change in the sample is detected with a monitor device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 illustrates an apparatus for performing a test on a fluid sample in accordance with the present invention.

[0016] FIG. 2 shows a cross-sectional view of one embodiment of a flow device according to the present invention.

[0017] FIG. 3 is a perspective view of another embodiment of a flow device according to the present invention.

[0018] FIGS. 4 and 5 show cross-sectional views of the device shown in FIG. 3.

[0019] FIG. 6 is a perspective view of yet another embodiment of a flow device according to the present invention.

[0020] FIG. 7 is a perspective view of a still further another embodiment of a flow device according to the present invention.

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